The Registration Program of BRCA1/2 Gene (RCA)

March 22, 2016 updated by: Chinese Anti-Cancer Association

The Registration Program of BRCA1/2 Gene in Chinese Breast Cancer Group

Purpose:

  1. Screening of large samples is to search the gene mutation of the breast cancer susceptibility gene (BRCA1 and BRCA2) in Chinese high risk group.
  2. To build the breast cancer BRCA1/2 mutation database of Chinese group.
  3. To build the hazard model of breast cancer BRCA1/2 mutation of Chinese group.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

It is the first large-scale and systematic study that fully recognize and review on the mutation spectrum of BRCA1/2 and the risk of Breast cancer in Chinese high risk group, it will be a Landmark research of susceptibility genes in Chinese breast cancer.

Study Type

Observational

Enrollment (Anticipated)

8000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100071
        • Recruiting
        • The 307th hospital of chinese People's liberation army
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ze-Fei Jiang, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Chinese Breast Cancer Patients

Description

Chinese Genetic/Familial breast cancer patients, and its first or second degree relatives with breast cancer (female or male).

The selection will be based on NCCN Clinical Practice Guidelines in Oncology (Genetic/Familial High-Risk Assessment: Breast and Ovarian).

Inclusion Criteria:

Patients: it must be from independent family and meet the one or more of the following conditions.

  1. Patients' age at diagnosis: 45 years or younger.
  2. Patients' age at diagnosis: 50 years or younger.

  3. Breast cancer patients: it must meet the one or more of the following family medical histories.

    3.1 Patients' age at diagnosis: 50 years or younger, and the one or more of the next of Kin has breast cancer.

    3.2 Patients' age at diagnosis: any of age, and the one or more of the next of Kin has breast cancer that its age at diagnosis was 50 years or younger.

    3.3 Patients' age at diagnosis: any of age, and the two or more of the next of Kin have breast cancer that its age at diagnosis was 50 years or younger.

    3.4 Patients' age at diagnosis: any of age, and the one or more of the next of Kin has epithelial ovarian cancer.

    3.5 Patients' age at diagnosis: any of age, and the two or more of the next of Kin have pancreatic cancer and/or prostate cancer (Gleason grading>7, any of age).

    3.6 Patients' age at diagnosis: any of age, and the one or more of the close-male relatives has breast cancer.

  4. Triple negative patients' age of onset: 60 years or younger.
  5. Patients: male and have breast cancer.

Patients' first or second degree relatives are BRCA1/2 mutation carrier (1-5 people):

First or second degree female adult relatives of patients (age: 18 years or older), it will be selected from the same paternal or maternal side according to the family disease.

First or second degree male relatives of patients have breast cancer.

Exclusion Criteria:

N/A.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
No treatment
There will be two groups, one is breast cancer patient group, another group inlude the first-degree relatives and second degree relatives of patients with BRCA1/2 mutation. All volunteers should provid tissue(s) and blood for NGS test.
Genetic: NGS test

To record the characteristic QC parameters and evaluate the detection performance of Next-Generation Sequencing (NGS), including coverage depth and sequence similarity, then be used to evaluate the quality of base recognition and alignment.

To know mutation characteristic spectrum of BRCA1/2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Screening of large samples is to search the gene mutation of the breast cancer susceptibility gene (BRCA1 and BRCA2) in Chinese high risk group.
Time Frame: About 2 years
About 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
To build the database of the Chinese breast cancer BRCA1/2 mutation.
Time Frame: About 2 years
About 2 years
To build the hazard model of Chinese breast cancer BRCA1/2 mutation.
Time Frame: About 2 years
About 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Anti-Cancer Association

Investigators

  • Principal Investigator: Ze-Fei Jiang, Doctor, 307 Hospital of PLA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

October 29, 2015

First Submitted That Met QC Criteria

October 29, 2015

First Posted (Estimate)

November 1, 2015

Study Record Updates

Last Update Posted (Estimate)

March 24, 2016

Last Update Submitted That Met QC Criteria

March 22, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBRCA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The data-sharing of the volunteers' genetic information need be discussed more.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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